On 25 May 2016, the Netherlands presidency of the Council of the EU together with representatives of the European Parliament reached political agreement regarding the new rules on medical devices and in vitro diagnostic medical devices (IVDs). These new rules come in the form of two draft regulations, which aim to ensure that medical devices and IVDs are safe, while also allowing patients to benefit from innovative health care solutions in a timely manner. The rules seek to achieve these aims through stricter controls for placing devices on the market and increased monitoring once the devices are available.
The new rules will also strengthen the regulation and surveillance of notified bodies; the independent entities responsible for assessing medical devices before they can be marketed. The agreement reached permits these bodies, which must ensure that they have qualified personnel, to carry out unannounced inspections of device manufacturing facilities.
It is expected that the Council’s Permanent Representatives Committee will be invited to endorse the agreement around mid-June 2016. The European Council will also be invited to confirm the agreement once the Parliament’s Committee on Environment, Public Health and Food Safety has confirmed acceptance of the compromise. The regulations must then be formally adopted by the Council and the Parliament before they can enter into force.
As the current overarching regulations for medical devices and IVDs have not been updated since the 1990s, the agreement to these draft regulations marks significant progress towards improving healthcare for all EU citizens and will be an interesting development to follow in the months and years to come.